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Medical-Device-Registration

Medical Devices Registration in Philippines

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    Government Authority

    In the Philippines, oversight of medical device registration falls under the jurisdiction of the Center for Device Regulation, Radiation Health, and Research (CDRRHR) within the Department of Health. (AMDD) ASEAN Medical Device Directive provided the list of documents needed for the registration of Medical Devices as per the Classification.

    Medical-Devices-Registration-in-Philippines

    The documents required for LTO for a medical device importer/distributor are:

    • Business Registration Certificate
    • Location Plan
    • Contract of lease of Space
    • Pharmacist Information
    • Product Listing
    • Floor Plan
    • Agreement with Medical Device Manufacturer for Distribution

    Time frame to obtain the LTO is between 1 – 3 months.

    Medical-Devices-Registration

    To facilitate this process, the PFDA requires the following documentation (General) for review:

    • ISO 13485
    • Free Sale Certificate from Country of Origin
    • Device Description
    • Features
    • Indications
    • Instruction for use
    • Pre-Clinical Studies
    • Clinical Studies
    • Shelf Life and Biocompatibility
    • Label
    • Risk Analysis
    • A brief summary of the sterilization method
    • Manufacturing Process

    Product Classification

    Classification Type Risk Level Review Time Application Fee
    Class A Notification (CMDN) Low 4 to 12 weeks for authentication PhP 7,500
    Class B Registration (CMDR) Low-moderate Within 6-9 months PhP 7,500
    Class C Registration (CMDR) Moderate-high Within 6-9 months PhP 7,500
    Class D Registration (CMDR) High Within 6-9 months PhP 7,500

    The current product classifications in the Philippines adhere to the ASEAN Medical Devices Directive, with categorizations ranging from low to high risk (Classes A, B, C, and D). The review time and registration fees vary according to the risk level. It’s important to note that In Vitro Diagnostic (IVD) devices have separate regulatory requirements under an upcoming Administrative Order.

    Validity & Renewal

    Aspect Details
    Validity Period CMDNs and CMDRs are valid for 5 years.
    Renewal Renewal must be done every five years after the initial approval.
    Renewal Filing Period Renewals can be filed 90 days before the expiry of the CMDR or CMDN.
    Renewal Fee A fee of PhP 5,150 (US $110) is applicable for renewal, which generates a fresh CMDN valid for 5 years.
    Registration Timeline 6 – 9 Months

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